10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarter ended March 31, 2009
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 000-13347
NEUROLOGIX, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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06-1582875 |
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(State or other jurisdiction
of incorporation or organization)
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(I.R.S. Employer Identification No.) |
One Bridge Plaza, Fort Lee, NJ 07024
(Address of principal executive offices)
(201) 592-6451
(Registrants telephone number, including area code)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the Registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the Registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See definition of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated file o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of May 1, 2009, 27,764,058 shares of common stock were outstanding.
TABLE OF CONTENTS
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Page |
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PART I. FINANCIAL INFORMATION |
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Item 1. Financial Statements |
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4 |
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5 |
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6 |
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10 |
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12 |
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19 |
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24 |
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24 |
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24 |
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24 |
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EX-31.1 |
EX-31.2 |
EX-32.1 |
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
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March 31, |
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December 31, |
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2009 |
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2008 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
16,885 |
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$ |
18,906 |
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Prepaid expenses and other current assets |
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301 |
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323 |
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Total current assets |
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17,186 |
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19,229 |
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Equipment,
less accumulated depreciation of $562 and $542 at March 31, 2009 and December 31, 2008, respectively |
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121 |
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141 |
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Intangible assets, less accumulated amortization of $200 and $182 at
March 31, 2009 and December 31, 2008, respectively |
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792 |
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748 |
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Other assets |
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5 |
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5 |
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Total Assets |
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$ |
18,104 |
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$ |
20,123 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
826 |
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$ |
850 |
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Total current liabilities |
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826 |
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850 |
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Derivative financial instruments, at estimated fair value Warrants |
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3,859 |
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Total liabilities |
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4,685 |
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850 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock; 5,000,000 shares authorized |
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Series A Convertible, $0.10 par value; 650 shares
designated, 645 shares issued and outstanding at March 31,
2009 and December 31, 2008, with an aggregate liquidation
preference of $1 |
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Series C Convertible, $0.10 par value; 700,000 shares
designated, 285,878 shares issued and outstanding at March
31, 2009 and December 31, 2008, with an aggregate liquidation
preference of $6,742 and $5,863 at March 31, 2009 and
December 31, 2008, respectively |
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29 |
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29 |
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Series D Convertible, $0.10 par value; 792,100 shares
designated, 734,898 shares issued and outstanding at March
31, 2009 and December 31, 2008, with an aggregate liquidation
preference of $28,642 and $27,031 at March 31, 2009 and
December 31, 2008, respectively |
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73 |
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73 |
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Common Stock: |
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$0.001 par value; 100,000,000 shares authorized, 27,764,058
issued and outstanding at March 31, 2009 and December 31,
2008 |
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28 |
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28 |
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Additional paid-in capital |
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56,271 |
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62,393 |
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Deficit accumulated during the development stage |
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(42,982 |
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(43,250 |
) |
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Total stockholders equity |
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13,419 |
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19,273 |
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Total Liabilities and Stockholders Equity |
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$ |
18,104 |
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$ |
20,123 |
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See accompanying notes to condensed financial statements.
4
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(Amounts in thousands, except share and per share amounts)
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For the period |
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February 12, 1999 |
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Three Months Ended |
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(inception) through |
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March 31, |
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March 31, 2009 |
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2009 |
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2008 |
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Revenues |
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$ |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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1,409 |
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1,082 |
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21,026 |
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General and administrative expenses |
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749 |
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922 |
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16,849 |
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Loss from operations |
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(2,158 |
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(2,004 |
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(37,875 |
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Other income (expense): |
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Dividend, interest and other income |
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33 |
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156 |
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1,859 |
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Interest expense related parties |
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(411 |
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Charge for change in estimated
fair value of derivative financial
instruments Warrants |
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(2,789 |
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(2,789 |
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Other income (expense), net |
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(2,756 |
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156 |
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(1,341 |
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Net loss |
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(4,914 |
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(1,848 |
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$(39,216 |
) |
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Preferred stock dividends |
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(717 |
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(589 |
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Net loss applicable to common stock |
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$ |
(5,631 |
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$ |
(2,437 |
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Net loss applicable to common stock
per share, basic and diluted |
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$ |
(0.20 |
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$ |
(0.09 |
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Weighted average common shares
outstanding, basic and diluted |
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27,764,058 |
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27,632,808 |
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See accompanying notes to condensed financial statements.
5
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
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Deficit |
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Accumulated |
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Additional |
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During the |
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Series D Preferred Stock |
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Series C Preferred Stock |
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Common Stock |
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Paid-in |
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Unearned |
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Development |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Compensation |
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Stage |
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Total |
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Sale of common stock to founders |
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$ |
0 |
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$ |
0 |
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6,004,146 |
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$ |
0 |
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$ |
4 |
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$ |
0 |
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$ |
0 |
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$ |
4 |
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Net loss |
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(328 |
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(328 |
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Balance, December 31, 1999 |
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$ |
0 |
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$ |
0 |
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6,004,146 |
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$ |
0 |
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$ |
4 |
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$ |
0 |
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$ |
(328 |
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$ |
(324 |
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Net loss |
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(1,055 |
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(1,055 |
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Balance, December 31, 2000 |
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$ |
0 |
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$ |
0 |
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6,004,146 |
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$ |
0 |
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$ |
4 |
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$ |
0 |
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$ |
(1,383 |
) |
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$ |
(1,379 |
) |
Stock options granted for services |
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9 |
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9 |
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Common stock issued for
intangible assets at $0.09 per
share |
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259,491 |
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24 |
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24 |
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Net loss |
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(870 |
) |
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(870 |
) |
Balance, December 31, 2001 |
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$ |
0 |
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$ |
0 |
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6,263,637 |
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$ |
0 |
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$ |
37 |
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$ |
0 |
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$ |
(2,253 |
) |
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$ |
(2,216 |
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Retirement of founder shares |
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(33,126 |
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Common Stock issued pursuant to
license agreement at $1.56 per
share |
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368,761 |
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577 |
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(577 |
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Private placement of Series B
convertible preferred stock |
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2,613 |
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2,613 |
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Amortization of unearned
compensation |
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24 |
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24 |
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Net loss |
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(1,310 |
) |
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(1,310 |
) |
Balance, December 31, 2002 |
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$ |
0 |
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$ |
0 |
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6,599,272 |
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$ |
0 |
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$ |
3,227 |
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$ |
(553 |
) |
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$ |
(3,563 |
) |
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$ |
(889 |
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Sale of Common Stock |
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276,054 |
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90 |
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(89 |
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1 |
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Amortization of unearned
compensation |
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164 |
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164 |
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Net loss |
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(2,274 |
) |
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(2,274 |
) |
Balance, December 31, 2003 |
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$ |
0 |
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$ |
0 |
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6,875,326 |
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$ |
0 |
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$ |
3,317 |
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|
$ |
(478 |
) |
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$ |
(5,837 |
) |
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$ |
(2,998 |
) |
Conversion of note payable to
Common Stock at $2.17 per share |
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1,091,321 |
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1 |
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2,371 |
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2,372 |
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Conversion of mandatory
redeemable preferred stock to
Common Stock |
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6,086,991 |
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6 |
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494 |
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500 |
|
Conversion of Series B
convertible preferred stock to
Common Stock |
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1,354,746 |
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1 |
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(1 |
) |
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Effects of reverse acquisition |
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7,103,020 |
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14 |
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5,886 |
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5,900 |
|
Amortization of unearned
compensation |
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|
202 |
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|
202 |
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6
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
During the |
|
|
|
|
Series D Preferred Stock |
|
Series C Preferred Stock |
|
Common Stock |
|
Paid-in |
|
Unearned |
|
Development |
|
|
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Capital |
|
Compensation |
|
Stage |
|
Total |
|
|
|
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42 |
|
|
|
(42 |
) |
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
|
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
15 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,937 |
) |
|
|
(2,937 |
) |
Balance, December 31, 2004 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
22,521,404 |
|
|
$ |
22 |
|
|
$ |
12,124 |
|
|
$ |
(318 |
) |
|
$ |
(8,774 |
) |
|
$ |
3,054 |
|
Sale of Common Stock through
private placement at an average
price of $1.30 per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,473,914 |
|
|
|
4 |
|
|
|
3,062 |
|
|
|
|
|
|
|
|
|
|
|
3,066 |
|
Sale of Common Stock at an
average price of $1.752 per share
and warrants to Medtronic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,141,552 |
|
|
|
1 |
|
|
|
2,794 |
|
|
|
|
|
|
|
|
|
|
|
2,795 |
|
Amortization of unearned
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
825 |
|
|
|
|
|
|
|
825 |
|
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,305 |
|
|
|
(1,305 |
) |
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
406,054 |
|
|
|
|
|
|
|
127 |
|
|
|
|
|
|
|
|
|
|
|
127 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,345 |
) |
|
|
(5,345 |
) |
Balance, December 31, 2005 |
|
|
|
|
|
$ |
0 |
|
|
|
|
|
|
$ |
0 |
|
|
|
26,542,924 |
|
|
$ |
27 |
|
|
$ |
19,412 |
|
|
$ |
(798 |
) |
|
$ |
(14,119 |
) |
|
$ |
4,522 |
|
Sale of Preferred Stock through
private placement at an average
price of $35.00 per share |
|
|
|
|
|
|
|
|
|
|
342,857 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
11,578 |
|
|
|
|
|
|
|
|
|
|
|
11,612 |
|
Fair value of beneficial
conversion rights issued in
connection with issuance of
Series C Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
|
|
|
|
|
|
|
|
|
|
2,621 |
|
Preferred Dividend and accretion
of fair value of beneficial
conversion charge |
|
|
|
|
|
|
|
|
|
|
25,298 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
|
|
|
|
(2,621 |
) |
|
|
(2,621 |
) |
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,193 |
|
|
|
|
|
|
|
|
|
|
|
1,193 |
|
Non-employee share-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83 |
|
|
|
|
|
|
|
|
|
|
|
83 |
|
Reclassification of prior year
non-employee compensation to
prepaid expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
487 |
|
|
|
|
|
|
|
487 |
|
Effects of adoption of SFAS 123R |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(311 |
) |
|
|
311 |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,046 |
) |
|
|
(7,046 |
) |
Balance, December 31, 2006 |
|
|
|
|
|
$ |
0 |
|
|
|
368,155 |
|
|
$ |
37 |
|
|
|
26,542,924 |
|
|
$ |
27 |
|
|
$ |
34,573 |
|
|
$ |
0 |
|
|
$ |
(23,786 |
) |
|
$ |
10,851 |
|
Sale of Series D Preferred Stock
through private placement at an
average price of $35.00 per share |
|
|
428,571 |
|
|
|
43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,727 |
|
|
|
|
|
|
|
|
|
|
|
14,770 |
|
7
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
During the |
|
|
|
|
Series D Preferred Stock |
|
Series C Preferred Stock |
|
Common Stock |
|
Paid-in |
|
Unearned |
|
Development |
|
|
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Capital |
|
Compensation |
|
Stage |
|
Total |
|
|
|
Fair value of beneficial
conversion rights issued in
connection with the issuance of
Series D Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,130 |
|
|
|
|
|
|
|
|
|
|
|
2,130 |
|
Preferred Dividend and accretion
of fair value of beneficial
conversion charge |
|
|
5,108 |
|
|
|
1 |
|
|
|
68,801 |
|
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
|
|
|
|
|
(2,130 |
) |
|
|
(2,130 |
) |
Contingent beneficial conversion
feature related to Series C
Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
627 |
|
|
|
|
|
|
|
(627 |
) |
|
|
|
|
Induced conversion of preferred
stock in connection with the
issuance of Series D Preferred
Stock |
|
|
163,470 |
|
|
|
16 |
|
|
|
(230,184 |
) |
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
|
(347 |
) |
|
|
|
|
|
|
354 |
|
|
|
|
|
Issuance of Series C Preferred
Stock in connection with induced
conversion of preferred stock |
|
|
|
|
|
|
|
|
|
|
93,940 |
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
2,949 |
|
|
|
|
|
|
|
(2,958 |
) |
|
|
|
|
Issuance of Common Stock in
connection with issuance of
Series D Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
192,017 |
|
|
|
|
|
|
|
192 |
|
|
|
|
|
|
|
(192 |
) |
|
|
|
|
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
702 |
|
|
|
|
|
|
|
|
|
|
|
702 |
|
Non-employee share-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72 |
|
|
|
|
|
|
|
|
|
|
|
72 |
|
Conversion of Series C Preferred
Stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
(5,597 |
) |
|
|
|
|
|
|
110,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
787,815 |
|
|
|
1 |
|
|
|
590 |
|
|
|
|
|
|
|
|
|
|
|
591 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,817 |
) |
|
|
(6,817 |
) |
Balance, December 31, 2007 |
|
|
597,149 |
|
|
$ |
60 |
|
|
|
295,115 |
|
|
$ |
30 |
|
|
|
27,632,808 |
|
|
$ |
28 |
|
|
$ |
56,207 |
|
|
$ |
0 |
|
|
$ |
(36,156 |
) |
|
$ |
20,169 |
|
Sale of Series D Preferred Stock
through private placement at an
average price of $35.00 per share |
|
|
142,857 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,918 |
|
|
|
|
|
|
|
|
|
|
|
4,932 |
|
Fair value of beneficial
conversion rights issued in
connection with the issuance of
Series D Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
562 |
|
|
|
|
|
|
|
|
|
|
|
562 |
|
Accretion of fair value of
beneficial conversion charge |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(562 |
) |
|
|
(562 |
) |
Contingent beneficial conversion
feature related to Series C
Preferred Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
212 |
|
|
|
|
|
|
|
(212 |
) |
|
|
|
|
Adjustment to preferred dividends
accrued |
|
|
(5,108 |
) |
|
|
(1 |
) |
|
|
(3,237 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
8
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIENCY)
FOR THE PERIOD FROM FEBRUARY 12, 1999 (INCEPTION) THROUGH MARCH 31, 2009
(UNAUDITED)
(Amounts in thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
During the |
|
|
|
|
|
|
Series D Preferred Stock |
|
|
Series C Preferred Stock |
|
|
Common Stock |
|
|
Paid-in |
|
|
Unearned |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Compensation |
|
|
Stage |
|
|
Total |
|
|
|
|
Employee shared-based
compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
489 |
|
Non-employee share-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
3 |
|
Conversion of Series C Preferred
Stock to Common Stock |
|
|
|
|
|
|
|
|
|
|
(6,000 |
) |
|
|
|
|
|
|
131,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,320 |
) |
|
|
(6,320 |
) |
Balance December 31, 2008 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
285,878 |
|
|
$ |
29 |
|
|
|
27,764,058 |
|
|
$ |
28 |
|
|
$ |
62,393 |
|
|
$ |
|
|
|
$ |
(43,250 |
) |
|
$ |
19,273 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee shared-based
compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
73 |
|
Non-employee
share-based
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
57 |
|
Cumulative effect of
adoption of EITF No.
07-05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,252 |
) |
|
|
|
|
|
|
5,182 |
|
|
|
(1,070 |
) |
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,914 |
) |
|
|
(4,914 |
) |
|
|
|
Balance March 31, 2009 |
|
|
734,898 |
|
|
$ |
73 |
|
|
|
285,878 |
|
|
$ |
29 |
|
|
|
27,764,058 |
|
|
$ |
28 |
|
|
$ |
56,271 |
|
|
$ |
|
|
|
$ |
(42,982 |
) |
|
$ |
13,419 |
|
|
|
|
See accompanying notes to condensed financial statements.
9
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period February |
|
|
|
|
|
|
|
|
|
|
12, 1999 (inception) |
|
|
Three Months Ended March 31, |
|
through |
|
|
2009 |
|
2008 |
|
March 31, 2009 |
|
|
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,914 |
) |
|
$ |
(1,848 |
) |
|
$ |
(39,216 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
20 |
|
|
|
29 |
|
|
|
568 |
|
Amortization |
|
|
18 |
|
|
|
14 |
|
|
|
340 |
|
Gain on redemption of investment |
|
|
|
|
|
|
|
|
|
|
(62 |
) |
Stock options granted for services |
|
|
|
|
|
|
|
|
|
|
9 |
|
Impairment of intangible assets |
|
|
|
|
|
|
29 |
|
|
|
194 |
|
Amortization of non-employee share-based compensation |
|
|
67 |
|
|
|
13 |
|
|
|
1,546 |
|
Share-based employee compensation expense |
|
|
73 |
|
|
|
119 |
|
|
|
2,457 |
|
Non-cash interest expense |
|
|
|
|
|
|
|
|
|
|
378 |
|
Charge for change in estimated fair value of derivative financial
instruments Warrants |
|
|
2,789 |
|
|
|
|
|
|
|
2,789 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and other current assets |
|
|
12 |
|
|
|
(12 |
) |
|
|
665 |
|
(Decrease) increase in accounts payable and accrued expenses |
|
|
(24 |
) |
|
|
(480 |
) |
|
|
765 |
|
|
|
|
Net cash used in operating activities |
|
|
(1,959 |
) |
|
|
(2,136 |
) |
|
|
(29,567 |
) |
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Security deposits paid |
|
|
|
|
|
|
|
|
|
|
(7 |
) |
Purchases of equipment |
|
|
|
|
|
|
(1 |
) |
|
|
(575 |
) |
Additions to intangible assets |
|
|
(62 |
) |
|
|
(46 |
) |
|
|
(1,296 |
) |
Proceeds from redemption of investment |
|
|
|
|
|
|
|
|
|
|
65 |
|
Purchases of marketable securities |
|
|
|
|
|
|
|
|
|
|
(12,673 |
) |
Proceeds from maturities of marketable securities |
|
|
|
|
|
|
|
|
|
|
12,673 |
|
|
|
|
Net cash used in investing activities |
|
|
(62 |
) |
|
|
(47 |
) |
|
|
(1,813 |
) |
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from note payable |
|
|
|
|
|
|
|
|
|
|
1,100 |
|
Borrowings from related party |
|
|
|
|
|
|
|
|
|
|
2,000 |
|
Cash acquired in Merger |
|
|
|
|
|
|
|
|
|
|
5,413 |
|
Merger-related costs |
|
|
|
|
|
|
|
|
|
|
(375 |
) |
Payments of capital lease obligations |
|
|
|
|
|
|
|
|
|
|
(99 |
) |
Proceeds from exercise of stock options |
|
|
|
|
|
|
|
|
|
|
733 |
|
Proceeds from issuance of common stock and warrants |
|
|
|
|
|
|
|
|
|
|
5,066 |
|
Proceeds from issuance of preferred stock |
|
|
|
|
|
|
|
|
|
|
34,427 |
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
|
|
48,265 |
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(2,021 |
) |
|
|
(2,183 |
) |
|
|
16,885 |
|
Cash and cash equivalents, beginning of period |
|
|
18,906 |
|
|
|
20,157 |
|
|
|
|
|
|
|
|
10
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the period February |
|
|
|
|
|
|
|
|
|
|
12, 1999 (inception) |
|
|
Three Months Ended March 31, |
|
through |
|
|
2009 |
|
2008 |
|
March 31, 2009 |
|
|
|
Cash and cash equivalents, end of period |
|
$ |
16,885 |
|
|
$ |
17,974 |
|
|
$ |
16,885 |
|
|
|
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Dividends on Series C Preferred Stock paid in preferred shares |
|
$ |
|
|
|
$ |
|
|
|
$ |
1,811 |
|
Accrued dividends on Preferred Stock |
|
$ |
717 |
|
|
$ |
589 |
|
|
$ |
3,661 |
|
Accretion of fair value of beneficial conversion on preferred stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
5,313 |
|
Accretion of contingent beneficial conversion related on Series C
Preferred Stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
839 |
|
Induced conversion of preferred stock in connection with issuance of
Series D Preferred Stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
2,796 |
|
Issuance of Common Stock to pay debt |
|
$ |
|
|
|
$ |
|
|
|
$ |
2,372 |
|
Reverse acquisition net liabilities assumed, excluding cash |
|
$ |
|
|
|
$ |
|
|
|
$ |
(214 |
) |
Mandatory redeemable convertible preferred stock converted to Common
Stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
500 |
|
Common Stock issued to acquire intangible assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
24 |
|
Stock options granted for services |
|
$ |
|
|
|
$ |
|
|
|
$ |
1,424 |
|
Deferred research and development cost resulting from Medtronic Stock
Purchase |
|
$ |
|
|
|
$ |
|
|
|
$ |
795 |
|
Acquisition of equipment through capital leases |
|
$ |
|
|
|
$ |
|
|
|
$ |
106 |
|
See accompanying notes to condensed financial statements.
11
NEUROLOGIX, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to Unaudited Condensed Financial Statements
(In thousands, except for share and per share amounts)
(1) Description of Business
Neurologix, Inc. (Neurologix or the Company), is engaged in the research
and development of proprietary treatments for disorders of the brain and central nervous system,
primarily utilizing gene therapies. These treatments are designed as alternatives to conventional
surgical and pharmacological treatments. The Company has not generated any operating revenues and,
accordingly, it is a development stage company.
The Company incurred net losses of $4,914, $1,848 and $39,216 and negative cash flows from
operating activities of $1,959, $2,136 and $29,567 for the three months ended March 31, 2009 and
2008 and for the period from February 12, 1999 (inception) to March 31, 2009, respectively. The
Company expects that it will continue to incur net losses and cash flow deficiencies from operating
activities for the foreseeable future.
The Company had cash and cash equivalents of $16,885 and $18,906 as of March 31, 2009 and
December 31, 2008, respectively. Management believes that the Companys current resources will
enable it to continue as a going concern through at least June 30, 2010. The Companys existing
resources, however, are not sufficient to allow it perform all of the clinical trials required for
drug approval and marketing. Accordingly, it will, from time to time, continue to seek additional
funds through public or private equity offerings, debt financings or corporate collaboration and
licensing arrangements. The Company does not know whether additional financing will be available
when needed, or, if available, will be on acceptable or favorable terms to it or its stockholders.
(2) Basis of Presentation
The accompanying unaudited condensed financial statements of the Company should be read in
conjunction with the audited financial statements and notes thereto included in the Companys
Annual Report on Form 10-K for the year ended December 31, 2008 (the 2008 10-K) filed
with the Securities and Exchange Commission (the SEC) on March 25, 2009. The accompanying
financial statements have been prepared in accordance with accounting principles generally accepted
in the United States (GAAP) for interim financial information, the instructions to Form
10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the
accompanying financial statements do not include all of the information and notes required by GAAP
for annual financial statements, but reflect all adjustments consisting of normal, recurring
adjustments, that are necessary for a fair presentation of the financial position, results of
operations and cash flows for the interim periods presented. Interim results are not necessarily
indicative of results for a full year. The December 31, 2008 consolidated balance sheet
information was derived from the audited consolidated financial statements as of that date.
12
(3) Summary of Significant Accounting Policies
(a) Stock-Based Compensation:
At March 31, 2009, the Company had one active share-based employee compensation plan available
for employees, non-employee directors and consultant grants. Stock option awards granted from this
plan are granted at the fair market value on the date of grant, and vest over a period determined
at the time the options are granted, ranging from zero to three years, and generally have a maximum
term of ten years. Certain options provide for accelerated vesting if there is a change in control
(as defined in the plans) or if there is a termination of employment event for specified reasons
set forth in certain employment agreements. When options are exercised, new shares of the Companys
common stock, par value $0.001 per share (the Common Stock), are issued.
Effective January 1, 2006, the Company adopted SFAS No. 123R, Share-based Payment (SFAS
123R), for employee stock options and other share-based compensation using the modified
prospective method. No share-based employee compensation cost had been reflected in net loss prior
to the adoption of SFAS 123R.
The total value of the stock option awards is expensed ratably over the service period of the
employees receiving the awards. As of March 31, 2009, total unrecognized compensation cost related
to stock option awards, to be recognized as expense subsequent to March 31, 2009, was approximately
$94, and the related weighted-average period over which it is expected to be recognized was
approximately 1 year.
The amount of compensation expense recognized under SFAS 123R during the three months ended
March 31, 2009 and 2008 was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2009 |
|
2008 |
|
|
|
Research and development |
|
$ |
18 |
|
|
$ |
37 |
|
General and administrative |
|
|
55 |
|
|
|
82 |
|
|
|
|
Share-based compensation expense |
|
$ |
73 |
|
|
$ |
119 |
|
|
|
|
Net share-based compensation expenses
per basic and diluted common share |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
|
|
13
A summary of option activity as of March 31, 2009 and changes during the three months then
ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
Shares |
|
Weighted- Average |
|
Remaining |
|
Aggregate |
|
|
Subject to Option |
|
Exercise |
|
Contractual |
|
Intrinsic |
Options |
|
(000) |
|
Price |
|
Term (years) |
|
Value |
Outstanding at December 31, 2008 |
|
|
3,623 |
|
|
$ |
1.38 |
|
|
|
6.60 |
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(8 |
) |
|
|
0.62 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2009 |
|
|
3,615 |
|
|
$ |
1.38 |
|
|
|
6.41 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2009 |
|
|
2,603 |
|
|
$ |
1.59 |
|
|
|
5.91 |
|
|
$ |
0 |
|
The fair value of the options is estimated under SFAS 123R on the date of grant using the
Black-Scholes option valuation model. Expected volatility is based on historical volatility of the
Common Stock. The risk-free rate is based on the five-year U.S. Treasury security rate.
The expected option term represents the period that stock-based awards are expected to be
outstanding based on the simplified method provided in Staff Accounting Bulletin No. 107 (SAB
107) which averages an awards weighted-average vesting period and expected term for plain
vanilla share options. Under SAB 107, options are considered to be plain vanilla if they have
the following basic characteristics: granted at-the-money; exercisability is conditioned upon
service through the vesting date; termination of service prior to vesting results in forfeiture;
limited exercise period following termination of service; and options are non-transferable and
non-hedgeable.
In December 2007, the SEC issued Staff Accounting Bulletin No. 110 (SAB 110). SAB
110 was effective January 1, 2008 and expresses the views of the Staff of the SEC with respect to
extending the use of the simplified method, as discussed in SAB 107, in developing an estimate of
the expected term of plain vanilla share options in accordance with SFAS 123R. The Company will
continue to use the simplified method until it has the historical data necessary to provide a
reasonable estimate of expected life in accordance with SAB 107, as amended by SAB 110. For the
expected term, the Company has plain-vanilla stock options, and therefore used a simple average
of the vesting period and the contractual term for options granted subsequent to January 1, 2006 as
permitted by SAB 107.
There were no options granted during the three months ended March 31, 2009 or March 31, 2008.
14
For equity awards to non-employees, the Company also applies the Black-Scholes option
valuation model to determine the fair value of such instruments in accordance with SFAS 123R and
Emerging Issues Task Force Issue 96-18, Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods, or
Services. The options granted to non-employees are re-measured as they vest and the resulting
value is recognized as an adjustment against our net loss over the period during which the services
are received.
(b) Basic and Diluted Net Loss Per Common Share:
Basic net loss per common share excludes the effects of potentially dilutive securities and is
computed by dividing net loss applicable to common stock by the weighted average number of common
shares outstanding for the period. Diluted net income or loss per common share is adjusted for the
effects of convertible securities, options, warrants and other potentially dilutive financial
instruments only in the periods in which such effects would have been dilutive.
The following outstanding securities were not included in the computation of diluted net loss
per share because to do so would have had an anti-dilutive effect for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
2009 |
|
2008 |
Stock options |
|
|
3,615,833 |
|
|
|
2,877,333 |
|
Warrants |
|
|
7,441,920 |
|
|
|
6,364,334 |
|
Common Stock issuable upon conversion of Series
A Convertible Preferred Stock |
|
|
645 |
|
|
|
645 |
|
Common Stock issuable upon conversion of Series
C Convertible Preferred Stock |
|
|
7,060,856 |
|
|
|
6,477,020 |
|
Common Stock issuable upon conversion of Series
D Convertible Preferred Stock |
|
|
24,216,821 |
|
|
|
18,328,284 |
|
(c) Derivative Instruments:
The Company accounts for derivatives in accordance with SFAS No. 133, Accounting for
Derivative Instruments and Hedging Activities (SFAS 133), which provides accounting and
reporting standards for derivative instruments, including certain derivative instruments embedded
in other contracts. All derivatives are recorded on the Companys statement of financial position
at fair value in accordance with current accounting guidelines for such complex financial
instruments. (See Note 4 and Note 5).
15
Effective January 1, 2009, the Company adopted Statement of Financial Accounting Standards No.
161, Disclosures about Derivative Instruments and Hedging Activitiesan amendment of FASB
Statement No. 133 (SFAS 161). SFAS 161 requires entities that utilize derivative
instruments to provide qualitative disclosures about their objectives and strategies for using such
instruments, as well as any details of credit-risk-related contingent features contained within
derivatives. SFAS 161 also requires entities to disclose additional information about the amounts
and location of derivatives located within the financial statements, how the provisions of SFAS 133
have been applied, and the impact that hedges have on an entitys financial position, financial
performance, and cash flows. The Companys derivative liabilities are related to warrants issued
in connection with financing transactions and are therefore not designated as hedging instruments.
(d) Financial Instruments and Fair Value:
Effective January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements
(SFAS 157), for financial assets and liabilities. SFAS 157 establishes a fair value
hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The
hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level
3 measurements). The three levels of the fair value hierarchy under SFAS 157 are described below:
Level 1 Unadjusted quoted prices in active markets that are accessible at the
measurement date for identical, unrestricted assets or liabilities;
Level 2 Quoted prices in markets that are not active or financial instruments for
which all significant inputs are observable, either directly or indirectly; and
Level 3 Prices or valuations that require inputs that are both significant to the
fair value measurement and unobservable.
In estimating the fair value of the Companys derivative liabilities, the Company used the
probability-weighted Black-Scholes option pricing model. (See Note 4 and Note 5).
(e) Recent Accounting Pronouncements:
Effective January 1, 2009, the Company adopted FASB Staff Position No. FAS 157-2, Partial
Deferral of the Effective Date of Statement 157 (FSP 157-2). FSP 157-2 delayed the
effective date of SFAS 157 for all nonfinancial assets and nonfinancial liabilities, except those
that are recognized or disclosed at fair value in the financial statements on a recurring basis (at
least annually) to fiscal years beginning after November 15, 2008. The adoption of FSP 157-2 did
not have a material impact on the Companys consolidated financial position, results of operations
or cash flows.
(4) Derivative Financial Instruments
Effective January 1, 2009, the Company adopted EITF Issue No. 07-05, Determining Whether an
Instrument (or Embedded Feature) Is Indexed to an Entitys Own Stock (EITF 07-05). EITF
07-05 clarifies the determination of whether an instrument issued by an entity (or an
16
embedded feature in the instrument) is indexed to an entitys own stock, which would qualify
as a scope exception under SFAS 133.
Based upon the Companys analysis of the EITF 07-05 criteria, certain warrants (the
Warrants) issued in connection with the issuance of the Series C Convertible Preferred
Stock, par value $0.10 per share, and the Series D Convertible Preferred Stock, par value $0.10 per
share, must now be treated as derivative liabilities in the Companys statement of financial
position. Prior to the adoption of EITF 07-05, the Company accounted for the Warrants as components
of stockholders equity under SFAS 133.
Consistent with EITF 07-05s requirements, the Company recognized the cumulative effect of the
change in accounting principle to reduce the opening balance of the deficit accumulated during the
development stage for fiscal year 2009. The cumulative effect adjustment of $5,182 represents the
difference between the amounts recognized in the statement financial position before initial
application of EITF 07-05 on January 1, 2009. Additionally, the initial fair value of the
Warrants, aggregating $6,252, which were initially recorded as additional paid-in capital upon
issuance, was reclassified to long-term liabilities upon adoption of EITF 07-05. The amounts
recognized at initial issuance were determined based on the estimated fair value of the Warrants
using a probability-weighted Black-Scholes option pricing model. Prospectively, the Warrants will
be re-measured at each balance sheet date based on estimated fair value, and any resultant changes
in fair value will be recorded as non-cash valuation adjustments within other income (expense) in
the Companys statement of operations. During the three months ended March 31, 2009, the Company
recorded other expense of $2,789 relating to the change in fair value of the Warrants during this
period.
The Company estimates the fair value of the Warrants using the probability-weighted
Black-Scholes option pricing model. The assumptions used for the three months ended March 31, 2009
are noted in the following table:
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Three Months Ended |
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March 31, 2009 |
Expected option term |
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5 to 7 years |
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Risk-free interest rate |
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1.87% - 2.28% |
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Expected volatility |
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117% |
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Dividend yield |
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0% |
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Expected volatility is based on historical volatility of the Companys common stock. The
Warrants have a transferability provision and based on guidance provided in SAB 107 for options
issued with such a provision, we used the full contractual term as the expected term of the
Warrants. The risk free rate is based on the five-year and seven-year U.S. Treasury security
rates.
(5) Fair Value Measurements
The following table presents the Companys liabilities that are measured and recognized at
fair value on a recurring basis classified under the appropriate level of the fair value hierarchy
as of March 31, 2009:
17
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Quoted |
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Prices in |
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Active |
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Markets |
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for |
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Significant |
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Identical |
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Other |
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Significant |
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Assets and |
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Observable |
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Unobservable |
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Balance as |
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Liabilities |
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Inputs |
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Inputs |
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of March |
Description |
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(Level 1) |
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(Level 2) |
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(Level 3) |
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31, 2009 |
Derivative
liabilities related
to Warrants |
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$ |
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$ |
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$ |
3,859 |
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$ |
3,859 |
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The following table sets forth a summary of changes in the fair value of the Companys Level 3
liabilities for the three months ended March 31, 2009:
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Cumulative |
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Effect of the |
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Adoption of |
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Balance as |
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December |
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EITF 07-05 |
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Unrealized |
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of March |
Description |
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31, 2008 |
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(See Note 4) |
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Losses |
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31, 2009 |
Derivative
liabilities related
to Warrants |
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$ |
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$ |
1,070 |
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$ |
2,789 |
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$ |
3,859 |
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The unrealized losses on the derivative liabilities are classified in other expenses as a
change in derivative liabilities in the Companys statement of operations. Fair value is
determined based on a probability-weighted Black-Scholes option pricing model calculation. (See
Note 4).
A financial instruments level within the fair value hierarchy is based on the lowest level of
any input that is significant to the fair value measurement. At each reporting period, the Company
performs a detailed analysis of the assets and liabilities that are subject to SFAS 157. At each
reporting period, all assets and liabilities for which the fair value measurement is based on
significant unobservable inputs or instruments which trade infrequently and therefore have little
or no price transparency are classified as Level 3.
(6) Commitments and Contingencies
License Agreement:
On January 13, 2009, the Company entered into a License Agreement (the Cornell License
Agreement), with Cornell University (Cornell), whereby Cornell granted the Company
an exclusive license for the worldwide use of certain patents for the development of products and
methods for the treatment of psychiatric conditions. Under the terms of the Cornell License
Agreement, the Company paid Cornell an initial fee, and, during the term of the Cornell License
Agreement, will pay Cornell an annual license maintenance fee and certain milestone and royalty
payments as provided for in the Cornell License Agreement. In addition, the Company agreed to continue providing
18
research support to Cornell under the Clinical Study Agreement during the
term of the Cornell License Agreement.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with the unaudited financial statements
and accompanying notes in this quarterly report on Form 10-Q and the audited financial statements
and notes thereto as of and for the year ended December 31, 2008 included in the 2008 10-K.
Operating results are not necessarily indicative of results that may occur in future periods. All
amounts in this Item 2 are in thousands.
Business Overview
The Company is a development stage company that is engaged in the research and development of
proprietary treatments for disorders of the brain and central nervous system using gene transfer
and other innovative therapies. These treatments are designed as alternatives to conventional
surgical and pharmacological treatments.
To date, the Company has not generated any operating revenues and has incurred annual net
losses. From inception through March 31, 2009, the Company had an accumulated deficit of $42,982,
and it expects to incur additional losses for the foreseeable future. The Company recognized net
losses of $4,914 for the three months ended March 31, 2009, and $1,848 for the three months ended
March 31, 2008.
Since its inception, the Company has financed its operations primarily through sales of its
equity and debt securities. From inception through March 31, 2009, the Company received proceeds
primarily from private sales of equity and debt securities and from its merger in February 2004 of
approximately $44,531 in the aggregate.
The Company has devoted a significant portion of its capital resources to the research and
development of its products. The Companys primary efforts are directed to the development of a
therapeutic product to meet the needs of patients suffering from Parkinsons disease.
In addition to its product for Parkinsons disease, the Company is undertaking efforts to
develop products for the treatment of Huntingtons disease and temporal lobe epilepsy
(TLE). The Company believes that its current resources are sufficient to conduct a
clinical trial for its Huntingtons disease product. Such trial would be conducted in a foreign
location and would involve human patients who will receive a brain infusion of the Companys
gene-based treatment for the disease. The timing of such trial is subject to the availability of
the adeno-associated virus (AAV) vector and an infusion system, and to the receipt of
applicable regulatory approvals. The Company does not anticipate using its current funds for the
further development of its TLE product at this time. See Plan of Operation Epilepsy and Plan
of Operation Huntingtons disease below.
19
Plan of Operation
Parkinsons Disease
In October 2006, the Company announced that it had completed its Phase 1 clinical trial for
Parkinsons disease. The results of this trial indicate that the treatment appears to be safe and
well-tolerated in trial participants with advanced Parkinsons disease, with no evidence of adverse
effects or immunologic reaction related to the study treatment. The trial, in which treatment was
confined to only one side of the brain, also yielded statistically significant clinical efficacy
and neuroimaging results. The results were peer-reviewed and published in the June 23, 2007 issue
of the journal The Lancet and the online edition of the Proceedings of the National Academy of
Sciences in November 2007.
In December 2008, the Company initiated a Phase 2 clinical trial for Parkinsons disease.
This trial is a randomized, controlled study designed to further establish the effectiveness and
the safety of the treatment. The trail is being conducted in multiple medical centers throughout
the U.S. with an expected 40 trial participants, 20 of which will be randomly selected to receive
the treatment and 20 of which will be randomly selected to receive a sterile saline solution. The
Company expects to conclude the surgeries for its Phase 2 clinical trial in the second half of 2009
and announce initial efficacy data in the first half of 2010.
The Company will take steps to move toward a pivotal trial for treatment of Parkinsons
disease, and hopes to be in a position to file its protocol with the U.S. Food and Drug
Administration (FDA) in 2010 or 2011. The Companys conduct of such trial will require,
among other things, approval by the FDA. Currently, the Company estimates that the pivotal trial
could be completed in 2013 and the estimated total costs to reach that milestone are expected to be
in excess of $20,000.
Huntingtons disease
In November 2005, the Company announced findings from pre-clinical studies which showed that a
form of the gene XIAP (X-linked Inhibitor of Apoptosis Protein or dXIAP) may prevent the
progression of Huntingtons disease. The Company further investigated the neuroprotective effects
of dXIAP by injecting presymptomatic rodents with AAV vectors encoding dXIAP into the striatum, an
area of the brain normally affected in Huntingtons patients. In the study, rodents injected with
this vector experienced significant reversal of motor dysfunction to the level of normal rodents,
while there was no improvement in rodents treated with a control vector. dXIAP also appeared to
prolong the lifespan of the rodents. Furthermore, no adverse effects due to dXIAP overproduction
were observed.
In August 2008, the Company entered into a license agreement with respect to an exclusive
license for the worldwide rights, excluding China, for the use of dXIAP for therapeutic or
prophylactic purposes in the treatment of Huntingtons disease.
The Companys development of this therapy for Huntingtons disease is currently in the
pre-clinical phase. The Company is planning to conduct a clinical trial for this therapy, the
timing of which is subject to the availability of the AAV vector and an infusion system, and to the
receipt of applicable regulatory approvals. Such trial would be conducted in a foreign
20
location and would involve human patients who will receive a brain infusion of the Companys
gene-based treatment for this disease.
Epilepsy
In December 2006, the Company submitted an investigational new drug application to the FDA for
permission to begin a Phase 1 clinical trial in TLE. The proposed clinical protocol for this study
was presented to the National Institute of Healths Office of Biotechnology Activities Recombinant
DNA Advisory Committee on September 23, 2004 and reviewed favorably.
During the second quarter of 2008, the Company learned that further action is required to
protect adequately the Companys intellectual property rights in its technology relating to its TLE
product. The Company recently discovered that certain individuals, not affiliated with the
Company, may also have rights to use certain technology currently used by the Company with respect
to the TLE product. If the Company elects to proceed with its Phase 1 clinical trial for its TLE
product, the Company will need to conduct an additional pre-clinical study in non-human primates,
which would be conducted in accordance with guidance received from the FDA.
Based on the foregoing, the commencement of a Phase 1 clinical trial for the Companys TLE
product will be subject, among other things, to the successful resolution of the above mentioned
intellectual property issues, to the successful completion of an additional pre-clinical study, the
availability of funding, concurrence by the FDA and procurement of related intellectual property
licenses.
Other Therapies
The Company will also continue its efforts in developing therapies to treat other
neurodegenerative and metabolic disorders, including depression and genetically-based obesity under
its research agreements with Cornell University for its Medical College and Ohio State University.
Future Operating Expenditures
Over the next 12 months, in addition to its normal recurring expenditures, the Company expects
to spend approximately $6,000 in Phase 2 clinical trial expenses with regard to its Parkinsons
treatment; $1,000 in costs associated with operating as a publicly traded company, such as legal
fees, accounting fees, insurance fees, insurance premiums, investor and public relations fees; $600
in clinical trial expenses with regard to its Huntingtons disease product; $700 in research and
licensing fees; and $200 in costs associated with scaling up its manufacturing capabilities for the
supply of product for a Parkinsons pivotal trial.
Results of Operations
Three Months Ended March 31, 2009 Compared to the Three Months Ended March 31, 2008
Revenues. The Company did not generate any operating revenues in the three months ended March
31, 2009 or in the three months ended March 31, 2008.
21
Costs and Expenses.
Research and Development. Research and development expenses increased by $327 during the three
months ended March 31, 2009 to $1,409 as compared to $1,082 during the comparable period in 2008.
The increase is mainly due to a $236 increase in fees related to license agreements and sponsored
research agreements, as well as a $102 increase in process development expenses for large scale
manufacturing of the Companys products and infusion devices and a $50 increase in non-cash
compensation to scientific consultants. This increase was offset by decreases, from the prior
comparable period, of $42 in clinical trial expenses associated with the Companys Parkinsons
disease product and $32 in employee compensation expenses.
General and Administrative. General and administrative expenses decreased by $173 to $749
during the three months ended March 31, 2009, as compared to $922 during the comparable period in
2008. This decrease was due, in part, to a $62 reduction in professional fees, including legal
fees, accounting fees, investor and public relations fees and recruiting fees, a $51 decrease in
employee compensation expenses, and a $29 reduction in patent impairment charges.
Other Income (Expense), Net. The Company had net other expenses of $2,756 during the three
months ended March 31, 2009, as compared to net other income of $156 during the comparable period
in 2008. The change is mainly due to a $2,789 charge incurred for the increase in estimated fair
value of its derivative liabilities during the three months ended March 31, 2009. Additionally,
the Company earned $123 less in interest income during the three months ended March 31, 2009 as
compared to the comparable period in 2008.
Liquidity and Capital Resources
Cash and cash equivalents were $16,885 at March 31, 2009.
The Company is a development stage company and has not generated any operating revenues as of
March 31, 2009. In addition, the Company will continue to incur net losses and cash flow
deficiencies from operating activities for the foreseeable future.
Based on its cash flow projections, the Company believes that its current resources will
enable it to continue as a going concern through at least June 30, 2010. The Companys existing
resources are not sufficient to allow it to perform all of the clinical trials required for drug
approval and marketing, including a pivotal trial for Parkinsons disease. Accordingly, it will
continue to seek additional funds through public or private equity offerings, debt financings or
corporate collaboration and licensing arrangements. The Company does not know whether additional
financing will be available when needed or, if available, will be on acceptable or favorable terms
to it or its stockholders.
Net cash used in operating activities was $1,959 for the three months ended March 31, 2009 as
compared to $2,136 during the comparable period in 2008. The $177 decrease in net cash used in
operations was due to a $480 decrease in cash used as a result of changes to working capital in
2009, offset by a $154 increase in operating expenses and a $123 decrease in interest income for
the three months ended March 31, 2009.
22
The Company had net cash used in investing activities of $62 during the three months ended
March 31, 2009 as compared to $47 during the three months ended March 31, 2008. Cash used in
investing activities relates to purchases of equipment and additions to intangible assets made by
the Company during 2009 and 2008.
The Company had no net cash used in or provided by financing activities during the three
months ended March 31, 2009 and 2008.
FORWARD-LOOKING STATEMENTS
This document includes certain statements of the Company that may constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act) and
which are made pursuant to the Private Securities Litigation Reform Act of 1995. These
forward-looking statements and other information relating to the Company are based upon the beliefs
of management and assumptions made by and information currently available to the Company.
Forward-looking statements include statements concerning plans, objectives, goals, strategies,
future events, or performance, as well as underlying assumptions and statements that are other than
statements of historical fact. When used in this document, the words expects, anticipates,
estimates, plans, intends, projects, predicts, believes, may, should, potential,
continue and similar expressions, are intended to identify forward-looking statements. These
statements reflect the current view of the Companys management with respect to future events and
are subject to numerous risks, uncertainties, and assumptions. Many factors could cause the actual
results, performance or achievements of the Company to be materially different from any future
results, performance, or achievements that may be expressed or implied by such forward-looking
statements, including, among other things:
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the inability of the Company to raise additional funds, when needed, through
public or private equity offerings, debt financings or additional corporate
collaboration and licensing arrangements; and |
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|
|
the inability of the Company to successfully commence and complete all necessary
clinical trials for the commercialization of its product to treat Parkinsons
disease. |
Other factors and assumptions not identified above could also cause the actual results to
differ materially from those set forth in the forward-looking statements. Additional information
regarding factors which could cause results to differ materially from managements expectations is
found in the section entitled Risk Factors contained in the 2008 10-K. Although the Company
believes these assumptions are reasonable, no assurance can be given that they will prove correct.
Accordingly, you should not rely upon forward-looking statements as a prediction of actual results.
Further, the Company undertakes no obligation to update forward-looking statements after the date
they are made or to conform the statements to actual results or changes in the Companys
expectations.
23
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable.
Item 4. Controls and Procedures
(a) Disclosure Controls and Procedures. The Company maintains disclosure controls and
procedures as required under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act,
that are designed to ensure that information required to be disclosed in the Companys Exchange Act
reports is recorded, processed, summarized and reported within the time periods specified in the
SECs rules and forms, and that such information is accumulated and communicated to the Companys
management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to
allow timely decisions regarding required disclosure.
As of March 31, 2009, the Companys management carried out an evaluation, under the
supervision and with the participation of the Companys Chief Executive Officer and Chief Financial
Officer, of the effectiveness of its disclosure controls and procedures. Based on the foregoing,
its Chief Executive Officer and Chief Financial Officer concluded that the Companys disclosure
controls and procedures were effective as of March 31, 2009.
(b) Changes in Internal Control Over Financial Reporting. There were no changes in the
Companys internal control over financial reporting that occurred during the period covered by this
report that have materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
PART II. OTHER INFORMATION
Item 6. Exhibits
See Exhibit Index.
24
Signatures
Pursuant to the requirements of the Securities Exchange Act of
1934, the Company has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
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NEUROLOGIX, INC.
|
|
May 11, 2009 |
/s/ John E. Mordock
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|
|
John E. Mordock |
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President and Chief Executive Officer
(as Principal Executive Officer) |
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May 11, 2009 |
/s/ Marc L. Panoff
|
|
|
Marc L. Panoff |
|
|
Chief Financial Officer, Secretary and Treasurer
(as Principal Accounting Officer/Principal Financial Officer) |
|
25
EXHIBIT INDEX
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Exhibit No. |
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Exhibit |
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31.1
|
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Rule 13a-14(a)/15d-14(a) Certification of President and Chief
Executive Officer (as Principal Executive Officer).** |
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31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial
Officer, Secretary and Treasurer (as Principal Accounting
Officer/Principal Financial Officer).** |
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|
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32.1
|
|
Section 1350 Certification of Chief Executive Officer and
Chief Financial Officer, Secretary and Treasurer.** |
26